Feasibility of Individualized, Model-guided Optimization of Proton Beam Treatment Planning in Patients With Low Grade Glioma

Low Grade Glioma Clinical Trial

— INDIGO  

Official title:

Prospective Phase II Trial to Assess Feasibility of Individualized, Model-guided Optimization of Proton Beam Treatment Planning in Patients With Low Grade Glioma Multicentric, Prospective Interventional, Randomized, Observer Blind Two Arm (Active Control), Parallel Group Investigator-initiated Phase II Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05964569
• Other study ID #: RadOnk-Indigo
• Status: Recruiting
• Phase: Phase 2
• Start date: November 11, 2023
• Est. completion date: November 11, 2028

Study information

• Verified date: January 2024
• Source: University Hospital Heidelberg
• Contact: Semi Harrabi, MD
• Phone: +496221 56
• Email: semi.harrabi[@]med.uni-heidelberg.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Low-grade glioma (LGG) represent typically slowly growing primary brain tumors with world health organization (WHO) grade I or II who affect young adults around their fourth decade. Radiological feature on MRI is a predominantly T2 hyperintense signal, LGG show typically no contrast uptake. Radiotherapy plays an important role in the treatment of LGG. However, not least because of the good prognosis with long term survivorship the timing of radiotherapy has been discussed controversially. In order to avoid long term sequelae such as neurocognitive impairment, malignant transformation or secondary neoplasms initiation was often postponed as long as possible

Description:

Since patients with low grade glioma are expected to become long-term survivors, the prevention of long-term sequelae is particularly important. In addition to disease progression, also treatment related side effects such as decline of neurocognitive function, endocrine impairment or sensorineural deficits can have a negative impact on patient's quality of life.

Owing to the biophysical properties of protons with an inverse depth dose profile compared to photons and a steep dose fall of to the normal tissue, there is a strong rationale for the use of PRT in the treatment of patients with low-grade glioma. Although data from large randomized trials are still missing there is increasing evidence from smaller prospective trials and retrospective analyses that the expected advantages indeed transform into clinical advantages.

However, in about 20 % of all patients, late contrast-enhancing brain lesions (CEBL) appear on follow-up MR images 6 - 24 months after treatment. At HIT in Heidelberg and at OncoRay in Dresden, CEBLs have been observed to occur at very distinct locations in the brain and relative to the treatment field. Retrospective analysis has elucidated potential key factors that lead to CEBL occurrence. However, avoidance of CEBLs is hardly feasible using conventional treatment planning strategies. Model-aided risk avoidance denotes the use of model-based CEBL risk calculations as an auxiliary tool for clinical treatment planning: Model-based risk calculations and risk reduction via software-based optimization help the clinician to minimize risk of CEBL occurrence during treatment planning.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: November 11, 2028
• Est. primary completion date: November 11, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age > 18 years

• histologically proven low-grade glioma

• indication for definitive or adjuvant radiotherapy

• ability to understand character and personal consequences of the clinical trial

• written informed consent

Exclusion Criteria:

• previous cerebral irradiation

• contraindication for contrast-enhanced MRI

• neurofibromatosis

• participation in another clinical trial with competing objectives

Related Conditions & MeSH terms

• Glioma
• Low Grade Glioma

Intervention

Other:
• model-guided optimization of treatment plan
original treatmant plans are optimized based on model-based NTCP
• standard treatment plan, no optimization
original treatment plans are not optimized

Locations

Country	Name	City	State
Germany	Department of Radiotherapy, University of Heidelberg	Heidelberg

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Heidelberg

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	incidence of contrast enhancing brain leasions	the cumulative incidence of contrast enhancing brain lesions	observed within 24 months after PRT measured by quarterly contrast enhanced MRI of the brain
Secondary	radiation-induced brain injuries	incidence of radiation-induced brain injuries > CTC°II	observed within 24 months after PRT measured by quarterly contrast enhanced MRI of the brain
Secondary	progression-free survival	number of surviving patients without tumor progression	observed within 24 months after PRT measured by quarterly contrast enhanced MRI of the brain
Secondary	overall survival	number of surviving patients	observed within 24 months after Proton Beam Therapy (PRT) measured by quarterly contrast enhanced MRI of the brain
Secondary	patient reported outcome	patient reported outcome according to points on the PRO-CTCAE questionaire, scored 0/1 for absent/present)	up to 24 months after completion of radiotherapy
Secondary	quality of life QLQ-C30	scores on the QLQ-C30 questionare, scored 0 (absence) to 5 (fully present)	up to 24 months after completion of PRT
Secondary	quality of life QLQ-BN20	scores on the QLQ-BN20 questionare, scored 0 (absence) to 5 (fully present)	up to 24 months after completion of PRT